Multihance at 3 Tesla in Brain Tumors - Full Text View

Sponsored by:	Bracco Diagnostics, Inc
Information provided by:	Bracco Diagnostics, Inc
ClinicalTrials.gov Identifier:	NCT00395863

Purpose

The purpose of this study is to evaluate whether Multihance is superior to Magnevist in terms of qualitative and quantitative assessment of unenhanced MRI and contrast-enhanced MRI for the visualization of brain disease.

Condition	Intervention	Phase
Brain Tumor	Drug: Multihance Drug: Magnevist	Phase IV

MedlinePlus related topics: Brain Cancer Cancer

Drug Information available for: Gadolinium DTPA

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Efficacy Study
Official Title:	A Phase IV Double-Blind Multicenter Randomized Crossover Study to Compare 0.10 Mmol/kg of Multihance With 0.10 Mmol.kg of Magnevist in Magnetic Resonance Imaging(MRI) of the Brain at 3T

Further study details as provided by Bracco Diagnostics, Inc:

Primary Outcome Measures:

Global preference between the two exams [ Time Frame: immediately post dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Global preference for border delineation of lesions; conspicuity of lesions; lesion count; LBR for each lesion; CNR for each lesion and percent enhancement [ Time Frame: immediately post dose ] [ Designated as safety issue: No ]

Enrollment:	46
Study Start Date:	November 2006
Study Completion Date:	March 2008
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Experimental	Drug: Multihance 0.5 M at a single injection Drug: Magnevist 0.5 M at a single dose injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years or older
Provide written informed consent
Scheduled for MRI
Confirmed or highly suspected to have brain tumor(s) and willing to undergo two MRI exams within 14 days

Exclusion Criteria:

Pregnant or lactating females
Allergy to one or more of the ingredients in the products or hypersensitivity to any metals
Congestive heart failure, class IV
Previous stroke in the past year
Received another contrast agent within 24 hours pre and post each exam
Investigational product
Contraindications to MRI
Severe claustrophobia
Surgery with 3 weeks prior
Steroid therapy or radiosurgery between two exams

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395863

Locations

United States, New Jersey
Bracco Diagnostics, Inc.
Princeton, New Jersey, United States, 08540

Sponsors and Collaborators

Bracco Diagnostics, Inc

Investigators

Study Director:

Gianpaolo Priovano, M.D.

Bracco Diagnostics, Inc

More Information

No publications provided

Responsible Party:	Bracco Dianostics, Inc ( Gianpaolo Pirovano, MD, Executive Director, Corporate Medical Development )
Study ID Numbers:	MH 126
Study First Received:	September 12, 2006
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00395863 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Brain Neoplasms
Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

Additional relevant MeSH terms:

Brain Neoplasms
Neoplasms
Neoplasms by Site
Nervous System Diseases

Central Nervous System Diseases
Central Nervous System Neoplasms
Brain Diseases
Nervous System Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009